On September 9, 2021, the Biden Administration announced a new plan to use federal regulatory powers to reduce the number of unvaccinated Americans. The thrust of the administrative initiative involves “substantially increas[ing] the number of Americans covered by vaccination requirements,” primarily through mandates that “will become dominant in the workplace.” The Administration estimates that these new mandates will affect over 80 million Americans eligible to be vaccinated but who have not yet gotten their first COVID-19 shot.
The dog days of summer are behind us, and National Back-to-School Month is well underway. Parents across the country are checking off tasks on their lists in order to get their college students ready to go back to school. If it’s not already on the list, parents need to make sure that their college student has appropriate health care documents in place for anything that comes their way.
On July 22, 2021, the Missouri Supreme Court issued its opinion in the matter of Ordinalo Velazquez v. University Physician Associates, et al. In a victory for health care providers, the Missouri Supreme Court rejected a constitutional challenge to non-economic damages caps in actions based on the provision of medical services.
On June 10, 2021, the Occupational Safety and Health Administration (“OSHA”) announced an action OSHA has not taken in 38 years: issuing an Emergency Temporary Standard (“ETS”). This ETS aims to protect “healthcare and healthcare support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.” The ETS does not go into effect until publication in the Federal Register, which has not yet occurred but appears imminent (OSHA has submitted the ETS to the Office of the Federal Register for publication and codification in 29 CFR 1910 Subpart U). The text of the ETS, as submitted to the Office of the Federal Register, is available here. OSHA also launched a website with resources regarding the ETS.
In late 2018, California passed a new law that will, in the near future, present sweeping changes to the pharmaceutical industry and certain medical device manufacturers. The new law amends the existing California Integrated Waste Management Act and is expected to be a boom for medical waste disposal companies who stand to obtain significantly more business. While the law was signed by the California Governor nearly two years ago, the regulations will go into effect in a few months (by January 1, 2021). The original bill, dubbed the “California Sharps and Drug Takeback Bill”, requires a manufacturer of covered drugs or home-generated sharps waste, to offer safe disposal methods for their customers’ used and unused products. The law has potentially sweeping affect because it encompasses all covered drugs and home generated sharps waste that are sold or offered for sale in California.
Employers beware, particularly those in healthcare sectors. If you provide a NIOSH-approved N95 “respirator” to protect employees from COVID-19, there are a number of OSHA respiratory protection standards that must be followed in a comprehensive Respiratory Protection Program. The Department of Labor OSHA’s July 21, 2020, national press release makes clear that OSHA will seek the maximum possible penalties for serious violations against companies that do not fully satisfy the respiratory protection standards.
Over the last couple of weeks, a great deal has been written about the steps hospitals should take as they begin to provide elective procedures again as the COVID-19 outbreak slowly subsides in some parts of the US. Lurking in the shadow of this issue is the question of what steps medical practices and outpatient clinics (“Medical Practices”) should take as they begin the process of returning to normal operations.
As I am sure you know, the U.S. Department of Health and Human Services (HHS) began distributing approximately $50 billion in Provider Relief Funds provided under the CARES Act between April 10 and April 17. The initial distribution of Provider Relief Funds (consisting of approximately $30 billion) was distributed among healthcare providers based on their “proportionate share of Medicare fee-for-service reimbursement for 2019”. For example, a provider with $15 million of Medicare FFS revenue in 2019 and $22 million in net patient revenue for 2018 would have received approximately $930,000 of Provider Relief Funds in the initial distribution: ($15,000,000/$484,000,000,000 (Total Medicare FFS Revenue for 2019) x $30,000,000,000).
On April 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) provided its initial guidance to hospitals and other healthcare facilities (collectively, “Hospitals”) as they begin to consider the timing for re-commencing normal operations as the COVID-19 outbreak begins to subside in some parts of the United States (the “Re-Opening Recommendations”). In a sense, the Re-Opening Recommendations are the bookend to the guidance CMS provided on March 18, 2020 recommending that Hospitals discontinue the provision of non-emergent and elective medical services and treatments during the COVID-19 outbreak. In each case, the guidance provided by CMS is neither legally mandated nor enforceable. Instead, the guidance merely provides a framework or frame of reference for use by Hospitals as they consider these decisions.
Many healthcare providers received an unanticipated cash infusion on or around April 10, 2020 (“Emergency Fund Payment”). Accompanying the payments was a list of terms and conditions attached to the funds. The U.S. Department of Health and Human Services (HHS) has stated that forms and additional information will be forthcoming; but in the meantime, the only available guidance is a letter to providers and the list of terms and conditions.